Cleared Traditional

PowerGlide Pro™ Midline Catheter (K240359) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K240359 · Becton, Dickinson and Company (Bard Access Systems, Inc.) · General Hospital
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Jul 2024
Decision
174d
Days
Class 2
Risk

K240359 is an FDA 510(k) clearance for the PowerGlide Pro™ Midline Catheter. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Becton, Dickinson and Company (Bard Access Systems, Inc.) (Salt Lake City, US). The FDA issued a Cleared decision on July 29, 2024 after a review of 174 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5200 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Becton, Dickinson and Company (Bard Access Systems, Inc.) devices

Submission Details

510(k) Number K240359 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 2024
Decision Date July 29, 2024
Days to Decision 174 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d slower than avg
Panel avg: 129d · This submission: 174d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FOZ Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5200
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FOZ Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days

All 127
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K240359.
Arrow™ Endurance™ Extended Dwell Peripheral Catheter System (EDC-00818)
K243599 · Arrow International, LLC (A subsidiary of Teleflex, Inc.) · Mar 2025
Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00620)
K242281 · Arrow International, LLC (A subsidiary of Teleflex, Inc.) · Dec 2024
SV Spectrum MRC Central Venous Catheter
K241115 · Spectrum Vascular · Nov 2024
Introcan Safety® 2 IV Catheter
K241845 · B.Braun Medical, Inc. · Jul 2024
AccuCath Ace™ Intravascular Catheter
K233106 · Bard Access Systems, Inc. (C.R. Bard, Inc.) · Apr 2024
Nouvo Safety Set
K232234 · Poly Medicure Limited · Mar 2024